Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia

NCT05666154 | Recruiting

• 1 other identifier: S65735
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

After a thorough baseline evaluation, functional dyspepsia (FD) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion. The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Responder rates in targeted diet vs sham diet

  Response defined by an improvement of minimum 0.5 points on the LPDS scale

  After 4 weeks of dietary intervention

Secondary Outcomes (5)

• Baseline duodenal transepithelial electrical resistance between groups

  At baseline

• Baseline duodenal flux of horse-radish peroxidase between groups

  At baseline

• Evolution of duodenal flux of horse-radish peroxidase between dietary interventions

  Baseline and after 4 weeks of diet

• Evolution of duodenal transepithelial electrical resistance between dietary interventions

  Baseline and after 4 weeks of diet

• Baseline mucosal immune cell composition between groups

  Baseline

Study Arms (4)

Real diet

ACTIVE COMPARATOR

Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE

Other: Real diet

Sham diet

SHAM COMPARATOR

Diet excluding a sham nutrient without acute mucosal reaction in CLE

Other: Sham diet

Wheat exclusion diet

ACTIVE COMPARATOR

In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy.

Other: Wheat exclusion diet

Soy exclusion diet

ACTIVE COMPARATOR

In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy.

Other: Soy exclusion diet

Interventions

Real diet OTHER

Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger)

Real diet

Sham diet OTHER

Diet excluding either sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger)

Sham diet

Wheat exclusion diet OTHER

Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger)

Wheat exclusion diet

Soy exclusion diet OTHER

Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger)

Soy exclusion diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 y/o (70 years included)
• Male or female subjects
• FD (PDS, EPS or overlap) according to Rome IV criteria
• Provide written informed consent to participate in the study
• Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
• Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.

You may not qualify if:

• Pregnant or breastfeeding women
• History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed)
• Symptoms predominantly associated with irritable bowel syndrome or gastro-esophageal reflux disease
• IgE-mediated food allergies identified by immunocaps blood tests
• Known underlying organic gastrointestinal disease
• Current use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). Use of antibiotics in the past 6 weeks.
• Allergy to Fluorescein or Propofol
• Known celiac disease
• Following a diet, interfering with the study diet in opinion to the investigators

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Central Study Contacts

Jolien Schol, MD

CONTACT

+3216345663; jolien.schol@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 27, 2022
• Study Start: December 5, 2021
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)